FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
.
Active Ingredient
(in each chewable tablet)
Simethicone 80 mg
Purpose
Antiflatulent
Uses
relieves
- bloating
- pressure
- discomfort of gas which can be caused by certain foods or air swallowing
Warnings
If pregnant or breast-feeding, ask a health professional before use.
Directions
- chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
- do not exceed 6 tablets per day unless directed by a physician
Other Information
- store at room temperature 15-30 °C (59-86 °F)
- protect from moisture
Inactive Ingredients
dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 80 mg |
| 4 | 67544-767-04 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20171222DKJ
Principal Display Panel - 80Mg
NDC 67544-767 Simethicone (MTAB) 80mg - Rx Only
* Please review the disclaimer below.